Samsung Bioepis Announces Clinical Results at the Korean Retina Society Conference
Samsung Bioepis announced on the 11th that ‘SB11’ (ingredient name ranibizumab), a macular degeneration biosimilar (biological drug generic), showed the same effect as the original drug in phase 3 clinical trials.
This product is a biosimilar of ‘Lucentis’ sold by multinational pharmaceutical companies Roche and Novartis.
Lucentis is used for eye diseases such as wet age-related macular degeneration and diabetic macular edema.
Samsung Bioepis conducted a global phase 3 clinical trial comparing SB11 and an original drug for patients with wet age-related macular degeneration, and announced the results at the ‘2022 Korean Retina Society Summer Conference’ held online on the same day.
The data presented today is for 634 patients who continued the prescription for 52 weeks out of 705 patients who participated in the clinical trial.
Samsung Bioepis measured the maximum corrected visual acuity for 8 weeks and the thickness of the macular center for 4 weeks following prescribing the drug as primary efficacy evaluation indicators, and in both indicators, equivalence with the original drug was confirmed.
Also, in the results of follow-up up to 52 weeks following prescription, there was no difference between SB11 and the original drug treatment group, and safety, pharmacokinetic properties, and immunogenicity were found to be the same.
“The clinical results confirmed that the efficacy, safety, and immunogenicity of SB11 and the original drug are equivalent,” said Woo Se-joon, a professor at Seoul National University Bundang Hospital, the lead researcher.
Samsung Bioepis’ SB11 was approved in Europe and the US in August and September last year, respectively, as ‘Baiwoobiz’ and in Korea in May this year as ‘Ameliebu’.
/yunhap news
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